Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement

Cardiovascular Disease Clinical Trial

— CAVIAR  

Official title:

Proposal for Collection of Patient Data to Aid in Design of an Observational Study (i.e. Preparatory to Research) Evaluating Risk of Cognitive Impairment After Surgical and Transcatheter Valve Replacement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971020
• Other study ID #: 4588-A
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: March 22, 2018
• Start date: May 2016
• Est. completion date: March 21, 2018

Study information

• Verified date: March 2018
• Source: Minnesota Veterans Medical Research and Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.

Description:

The investigators are conducting a pilot study to compare cognitive outcomes in up to 60 Veterans with severe aortic valve stenosis who are scheduled to undergo either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) at the Minneapolis VA Health Care System. Participants will be administered a short battery of cognitive tests before and three months after TAVR or SAVR over/up to a two year study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 21, 2018
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 104 Years

Eligibility

Inclusion Criteria:

• Severe aortic stenosis (AVA: 1 cm2 and/or mean gradient =or > 40 mmHg and/or peak velocity > 4 m/s)

• Scheduled to undergo either surgical or transcatheter aortic valve replacement at the Minneapolis VA Health Care System

Exclusion Criteria:

• Severe cognitive impairment at baseline (i.e. unable to understand or follow-up study procedures)

• Unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Cognitive Assessments
• Cognitive Dysfunction
• Surgical Valve Replacement
• Transcatheter Valve Replacement
• Valve Surgery

Intervention

Other:
• Observational/Cognitive Assessment
Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minnesota Veterans Medical Research and Education Foundation	Minneapolis Veterans Affairs Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment	Estimate the means and standard deviations of changes in selected cognitive measures between baseline (pre-TAVR or pre-SAVR) and 3 months post-TAVR or post-SAVR, identify baseline correlates of those changes, and characterize baseline cognitive function and cognitive history of patients who undergo TAVR or SAVR.	Three Months
Primary	Trail Making		3 months